Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: A placebo-controlled double-blind parallel-group study

Masayoshi Harigai, Yoshiya Tanaka, Shingo Maisawa, Kazuhide Tanimura, Hiroki Takahashi, Yukitomo Urata, Yasuhiko Hirabayashi, Tomonori Ishii, Hiroshi Fujii, Takayuki Sumida, Chihiro Terai, Ryutaro Matsumura, Makoto Sueishi, Kazuhiko Yamamoto, Akio Yamada, Daitaro Kurosaka, Akio Mimori, Yusuke Miwa, Masataka Kuwana, Shinichi KawaiYoshiaki Ishigatsubo, Kazunori Sugimoto, Noriyoshi Ogawa, Toshiaki Miyamoto, Shigenori Tamaki, Motokazu Kai, Daisuke Kawabata, Toshio Tanaka, Masaaki Inaba, Shunichi Kumagai, Akio Morinobu, Yasushi Miura, Hajime Sano, Naoki Kashihara, Yoshitaka Morita, Kazuhiko Ezawa, Yuji Yamanishi, Masanori Kawashima, Seizo Yamana, Mitsuhiro Iwahashi, Hiroaki Dobashi, Kiyoshi Takasugi, Takahiko Horiuchi, Eiichi Suematsu, Takaaki Fukuda, Katsumi Eguchi, Atsushi Kawakami

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21 Citations (Scopus)

Abstract

Objective. To evaluate the safety and efficacy of ocrelizumab (OCR) in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Methods. RA patients with an inadequate response to MTX 6-8 mg/week received an infusion of 50, 200, or 500 mg OCR or placebo on Days 1 and 15 and were observed for 24 weeks. The double-blind period was prematurely terminated because of a possible risk for serious infection from OCR. Results. A total of 152 patients were randomized into the study. The incidence of infection was 37.7% (43/114) in the OCR groups combined, compared to 18.9% (7/37) in the placebo group. Serious infections occurred in 7 patients in the OCR groups combined; there were no serious infections in the placebo group. Among the serious infections, Pneumocystis jirovecii pneumonia occurred in 2 patients in the OCR 200 mg group. The American College of Rheumatology 20% response rates at Week 24 (the primary endpoint) of the OCR 50, 200, and 500 mg groups were 54.1% (p = 0.0080), 55.6% (p = 0.0056), and 47.2% (p = 0.044), respectively, all significantly higher than that of the placebo group (25.0%). Conclusion. These results suggest inappropriate benefit-risk balance of OCR in this patient population. Because rituximab is not approved for treatment of RA in Japan, it will be necessary to investigate safety and efficacy of other anti-B cell therapies in Japanese patients with RA. The Journal of Rheumatology

Original languageEnglish
Pages (from-to)486-495
Number of pages10
JournalJournal of Rheumatology
Volume39
Issue number3
DOIs
Publication statusPublished - Mar 2012

All Science Journal Classification (ASJC) codes

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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